These approvals were supported by data from the Phase 3 ASCENT study, in which Trodelvy showed a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)) and improved median PFS in patients regardless of brain metastasis to 4.8 months from 1.7 months with chemotherapy (HR: 0.43 95% CI: 0.35-0.54 p1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). “We pursued innovative regulatory pathways, such as those made possible by Project Orbis, to help make Trodelvy available to patients as rapidly as possible.” “Because Trodelvy is the first and only targeted treatment to show benefit in overall survival in 2L metastatic TNBC versus chemotherapy, ensuring that it is accessible to eligible patients is imperative,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
Beyond the Project Orbis regulatory approvals, the European Medicines Agency validated a Marketing Authorization Application for Trodelvy in March and regulatory review is also underway in Kazakhstan and Saudi Arabia, as well as Singapore via licensing partner, Everest Medicines. Trop-2, a protein located on the surface of cells, is overexpressed in TNBC as well as other solid tumors. Trodelvy is a first-in-class Trop-2 directed antibody-drug conjugate. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) with international regulatory authorities as a global collaborative review program for high impact oncology marketing applications across participating countries. Project Orbis is an initiative of the U.S. Canada joins Australia, Great Britain, Switzerland, and the United States among the countries that have approved Trodelvy for use under Project Orbis. (Nasdaq: GILD) today announced that Health Canada has approved Trodelvy ® (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior therapies, at least one of them for metastatic disease. – Canada Joins Australia, Great Britain, Switzerland, and the United States in Approval of Trodelvy as a Second-Line Treatment Option for Adults with Metastatic TNBC – – Project Orbis is a Collaborative Review Program Intended for High-Impact Oncology Products – – Antibody-Drug Conjugate Trodelvy is First Treatment to Show Survival Benefit versus Standard of Care in Metastatic Triple-Negative Breast Cancer –
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